June 28, 2016
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Equetro

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Equetro




Equetro Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/5/2016

Equetro (carbamazepine xr) is an anticonvulsant (anti-seizure) medication used to treat seizures and nerve pain such as trigeminal neuralgia and diabetic neuropathy. Equetro is also used to treat bipolar disorder. Common side effects of Equetro include nausea, vomiting, dizziness, drowsiness, unsteadiness, dry mouth, swollen tongue, or loss of balance or coordination as your body adjusts to this medication.

The recommended initial dose of Equetro is 400 mg/day given in divided doses, twice daily. Many other medicines could cause a drug interaction if taken together with Equetro. Tell your doctor all medications and supplements you use. During pregnancy, Equetro should be used only when prescribed. It may harm a fetus. Since untreated bipolar disorder or seizures can be serious conditions, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, consult your doctor. If you are pregnant, prenatal care including tests for defects is recommended. Birth control pills, patches, implants, and injections may not work if taken with this medication. Discuss birth control with your doctor. This medication passes into breast milk. Consult your doctor before breastfeeding.

Our Equetro (carbamazepine xr) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Equetro in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: sudden mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, irritable, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • fever, tired feeling, weakness, confusion, pale skin, feeling light-headed or short of breath;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • slow, fast, or pounding heartbeats;
  • confusion, vision problems, hallucinations;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • little or no urinating;
  • swelling, rapid weight gain;
  • problems with your fingernails or toenails; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • dizziness, drowsiness,
  • nausea, vomiting, feeling unsteady;
  • dry mouth, swollen tongue; or
  • loss of balance or coordination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Equetro (Carbamazepine XR)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Equetro Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, dizziness, drowsiness, constipation, dry mouth, or unsteadiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mouth sores, swollen lymph nodes, persistent vomiting, severe stomach/abdominal pain, yellowing eyes/skin, dark urine, change in the amount of urine, persistent or severe headache, fainting, fast/slow/irregular heartbeat, unusual eye movements (nystagmus), vision changes (such as blurred vision), joint pain, swelling of the ankles/feet, pain/redness/swelling of the arms or legs, numbness/tingling of the hands/feet, sun sensitivity, signs of low levels of sodium in the blood (such as persistent nausea, extreme drowsiness, mental/mood changes including confusion, seizures).

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Equetro (Carbamazepine XR)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Equetro FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most commonly reported adverse reactions ( > 5% in the EQUETRO group and at least twice placebo) in the pooled 3-week placebo-controlled trials in patients with acute mania associated with Bipolar I Disorder (Studies 1 and 2) were dizziness, somnolence, nausea, vomiting, ataxia, constipation, pruritus, dry mouth, asthenia, rash, blurred vision, and speech disorder [see Clinical Studies]. The EQUETRO doses used were 400 to 1600 mg per day.

Table 2: Common Adverse Reactions Reported in Bipolar Disorder Studies 1 and 2 (Incidence > 2% and greater than placebo)

Adverse Reactions EQUETRO®
(N = 251)
Placebo
(N = 248)
Dizziness 44% 12%
Somnolence 32% 13%
Nausea 29% 10%
Vomiting 18% 3%
Ataxia 15% 0.4%
Constipation 10% 5%
Pruritus 8% 2%
Dry Mouth 8% 3%
Asthenia 8% 4%
Rash 7% 4%
Blurred vision 6% 2%
Speech Disorder 6% 0.4%
Hypertension 3% 0.4%
Paresthesia 2% 1%
Thinking abnormal 2% 0.4%
Tremor 3% 1%
Twitching 2% 1%
Vertigo 2% 1%

Postmarketing Experience

The following adverse reactions have been identified during post approval use of carbamazepine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nervous System: confusion, diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, tinnitus.

Digestive System: gastric distress, abdominal pain, diarrhea, anorexia.

Other: lupus erythematosus-like syndrome

One case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.

Read the entire FDA prescribing information for Equetro (Carbamazepine XR)

Equetro - User Reviews

Equetro User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Equetro sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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